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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 12 FDA drug recalls.

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DateProductReasonClassFirm
Nov 2, 2016 PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/... Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... Class II Fallon Wellness Pharmacy, L.L.C.
Nov 2, 2016 PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL ... Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon W... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Well... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellne... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 300... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmac... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mc... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fal... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon We... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.